| CTRI Number |
CTRI/2025/10/096490 [Registered on: 27/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of life among women treated for cervical cancer using advanced radiation methods. |
|
Scientific Title of Study
|
Assessment of quality of life of cervical cancer survivors treated with advanced radiation technique - a cross-sectional analytical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M J Kumari |
| Designation |
Professor cum principal (Ag), JIPMER |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education Research - [JIPMER] |
| Address |
Room no. 100, ground floor, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Room no. 100, ground floor, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894595420 |
| Fax |
|
| Email |
kumari_mj@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M J Kumari |
| Designation |
Professor cum principal (Ag), JIPMER |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education Research - [JIPMER] |
| Address |
Room no. 100, ground floor, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Room no. 100, ground floor, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
PONDICHERRY
605006
India |
| Phone |
9894595420 |
| Fax |
|
| Email |
kumari_mj@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Madhusmita Talukdar |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education Research - [JIPMER] |
| Address |
Room no. 102, first floor College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Room no. 102, first floor College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9101702419 |
| Fax |
|
| Email |
madhusmitatalukdar94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Intramural fund committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M J Kumari |
Radiation Oncology Department, Regional Cancer Center, JIPMER |
Room no. 86, ground floor, Radiation Oncology Department, Regional Cancer Center, JIPMER, JIPMER campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY |
09894595420
kumari_mj@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Nursing Courses (Human Studies), JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C53||Malignant neoplasm of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Patients at any stage of cervical cancer (International Federation of Gynaecology and Obstetrics- FIGO stage I, II, III, and IV).
Patients after completion of advanced radiation technique for more than 6 months to 3 years.
|
|
| ExclusionCriteria |
| Details |
Patients who progressed, cancer recurrence or metastasis had occurred.
Patients with severe comorbidities like vesico vaginal fistula and rectovaginal fistula
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| quality of life of cervical cancer survivors treated with advanced radiation techniques. |
single time assessment after survivors treated with advanced radiation techniques. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| association between socio-demographic and clinical variable with quality of life of cervical cancer survivors who have undergone advanced radiation therapy. |
single time assessment after survivors treated with advanced radiation techniques. |
|
|
Target Sample Size
|
Total Sample Size="194"
Sample Size from India="194"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to assess the quality of life (QoL)
of cervical cancer survivors who have completed treatment with advanced
radiation techniques (such as IMRT or IGRT) at JIPMER, Puducherry. Cervical
cancer remains a major public health issue in India, and while modern
radiotherapy has improved survival rates, long-term side effects can
significantly influence survivors’ physical, emotional, and social well-being. Using
standardized and validated tools — the EORTC QLQ-C30 and EORTC QLQ-CX24
questionnaires — the study evaluates multiple dimensions of QoL including
physical, psychological, social, and sexual functioning. It also explores the
relationship between socio-demographic and clinical factors (e.g., age, stage,
type of treatment) and QoL outcomes. This is a cross-sectional analytical study
involving 194 cervical cancer survivors treated at the Radiation Oncology OPD,
JIPMER. Participants are selected through convenience sampling. The expected
outcome is to generate evidence on how modern radiation techniques impact the
long-term QoL of Indian cervical cancer survivors. The findings will help
healthcare providers design better survivorship care plans, address
post-treatment complications, and improve the overall well-being of survivors. |